Board-eligible or board-certified genetic counselors and students evaluate a virtual reality-based intervention using questionnaires and physiological measurements.

Questionnaires completed before and after viewing virtual reality scenes, taking about 30 minutes to complete.

Questionnaires

Small sensors applied to skin will measure heart rate and sweat amounts while participants view a virtual reality scene.

Physiological Measurements

Prototype virtual reality application that demonstrates a provider-patient communication scenario commonly encountered in genetic counseling for hereditary cancers.

Virtual Reality Scene Viewing

Susan Peterson, PHD, MPH

The goal of this study is to evaluate a virtual reality-based intervention for training health care providers who are not genetics specialists to effectively communicate with and counsel patients regarding cancer genetics.

If you agree to take part in this study, you will complete questionnaires, have your physiological measurements recorded, and view virtual reality scenes.

Questionnaires:

You will fill out questionnaires before and after viewing the virtual reality scenes. Before viewing the virtual reality scenes, you will answer questions about your demographic, educational and professional background and about the likelihood of becoming engaged in a virtual environment. After viewing the virtual reality scenes, you will answer questions to evaluate the scenes. You also will be asked to provide additional comments about the virtual reality scenes during a brief interview. In total, these questionnaires should take about 30 minutes total to complete.

Physiological Measurements:

Your heart rate and the amount you sweat will be recorded during the virtual reality scene (described below) by applying small sensors to your skin.

After you have completed the first set of questionnaires, you will sit in a recliner and the sensors will be placed on your rib cage and hand. The sensors that measure heart rate will be placed in the following locations: your lower left rib cage, just under your right collar bone, and just under your left collar bone. The sensors that measure the amount you sweat will be placed on the palm of your hand.

The Virtual Reality Scenes:

You will sit in a recliner and be asked to put on a virtual reality helmet, which has goggles and noise-cancelling headphones. You will be told how to wear the helmet and use the hand-held controller.

You will first view a sample virtual reality scene to help orient you to the technology. The experience of virtual reality may involve multiple senses. For example, you may hear, smell, and feel sensations (such as mild vibrations) that are associated with the scenes you are viewing.

After you become comfortable using the technology, you will view a virtual reality scenario that depicts a typical session in cancer genetic counseling. The scenario will depict a virtual patient who is being seen for genetic counseling. You will be encouraged to speak to and interact with the virtual patient as you would with a real patient. The interaction with the virtual patient will be recorded. It is estimated that you will spend about 30 minutes in the genetic counseling scene with the virtual patient.

After the scene has ended, the equipment and sensors will be removed, and you will be asked to complete the second set of questionnaires and the brief interview.

It is expected that it will take up to 2 hours to complete all study procedures.

This is an investigational study.

Up to 21 people will take part in this study at M. D. Anderson.

Virtual Reality Intervention in Cancer Genetics

Developing Providers' Communication and Counseling Skills in Cancer Genetics Using Virtual Reality

Proof of concept for VR application established if VR prototype successfully evokes a sense of presence and co-presence (measured by the PQ and CPQ questionnaires, respectively). Responses to the PQ and CPQ given on a 7-point scale, with higher scores indicating higher degrees of presence and co-presence where mean scores above 4 considered high degree of presence and co-presence.

M.D. Anderson Cancer Center

Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Obesity

Newsletters, Physical Activity (PA) Prescription Plan, Pedometer

PA Prescription Plan

Pedometer

4 Newsletters with topics based on PA progression phases of adoption and maintenance.

Newsletters

Lorna H. McNeill, PHD, MPH

The goal of this study is to learn why some black and Latino men and women choose not to exercise very often. Researchers also want to learn more about any social and environmental factors that may affect the way an exercise program is followed.

If you chose to take part in this study, you will receive an exercise program, a pedometer, access to a social networking site, and newsletters to help you start becoming more physically active. A pedometer is a small device worn on the hip that counts the number of steps you have taken each day.

Study Visits:

You will come in for study visits 6 times while you are on study; 1 time at the beginning of the study called "screening", 1 time for an orientation visit 7 days after the screening visit, and for follow-up visits at 8, 26, 39, and 52 weeks after you begin the exercise program.

Baseline Tests:

If you are found to be eligible to take part on this study based on the results of the screening tests, the following tests and procedures will be performed:

* You will be asked to complete a computer-based survey. The questionnaires will ask questions about stress, your motivation for physical activity, any social support you may receive from others, the neighborhood you live in, and other physical activity-related topics. The questionnaires should take about 2 hours total to complete.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
* You will complete a fitness test. To complete the fitness test, you will either walk a circular path at the clinic for 6 minutes or complete a step test. The study staff will decide which test you will complete and will discuss the test with you in more detail. A study staff member will monitor you during this test.

Study Devices:

At the baseline visit, you will be given the following study devices:

* You will be given a smartphone to take home with you.
* You will fill out a set of questions on the smartphone each time you exercise. The questions will ask about the kind physical activity you are participating in, the location of where the physical activity is taking place, and the weather conditions outside. These questions will take about 1-2 minutes per day. Also, the smartphone will "beep" at random times (3 times per day) and set times (in the morning and evening) throughout the day to prompt you to answer a set of questions about your thoughts and feelings. The device will also automatically record your location using a Global Positioning System (GPS) during the time you are carrying the phone. This will take about 7-8 minutes per day. The research staff will call you 1 time each week to remind you to use the smartphone and will help with any smartphone problems that may occur. Each reminder phone call should last about 3 minutes. You will return the smartphone with you at the orientation visit for the study staff to download your answers.
* You will be given an accelerometer. You will wear the accelerometer for 7 days and then return it at the orientation study visit. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.

Orientation Study Visit:

At the orientation study visit, the following tests and procedures will be performed:

* You will be given a newsletter that contains information and strategies to help you start your exercise program.
* You will be given a smartphone again to take home.
* You will be given a physical activity (PA) prescription. The PA prescription outlines your exercise program and has instructions on the proper way to walk to decrease the chance of getting an injury. You will be instructed to start your PA prescription and carry the smartphone with you for 2 weeks. After 2weeks, you will return the smartphone by mail in a prepaid envelope that will be provided to you by the study staff.
* You will be given a pedometer to wear when you are ready to start your PA prescription.

Weeks 8, 26, 39, and 52 Study Visits:

For each of these study visits, the following tests and procedures will be performed:

* You will return the accelerometer at each visit for the study staff to review, and you will take it home at the end of each visit. The staff member will provide you with the device at your Week 8 visit and you will receive an envelope for return. The smartphone will also be given to you at Weeks 26 and 39, and you will be required to mail it back. For Week 52 you will receive the device 1 week before and return it at your Week 52 visit. You should tell a research staff member right away about any problems you may have using the smartphone.
* You will complete the computer-based survey.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured.

You will receive phone calls between study visits to remind you to complete the questions on the smartphone.

At the Weeks 26 and 52 study visits, in addition to the tests and procedures listed above, you will complete the fitness test again and return the smartphone.

Length of Study:

You will remain in the study for up to 1 year. Your participation on this study will be over after you complete the study visit at Week 52.

Other Information:

You may be contacted by phone, mail, text messaging, and/or email at any time while you are taking part in this study to be reminded about the study visits. You will be asked to give the names and contact information of family members and/or friends for the study staff to contact in the event they cannot reach you first.

This is an investigational study.

Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.

Social Contextual Influences on Physical Activity

Social, Contextual, and Environmental Determinants of Physical Activity in Sedentary Minority Adults

Physical Activity (PA) outcome measured at four time points post baseline (weeks 8, 26, 39, and 52)

National Cancer Institute (NCI)

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Participants will experience standard practice for lung cancer early detection.

Participants will experience standard practice for lung cancer early detection plus the intervention.

Patient navigated reminder calls containing information about screening appointments, reminders, hints to facilitate communication with physicians, and smoking cessation.

Patient Navigation

David Gerber

The study proposes to evaluate a patient navigation intervention among a sample of 446 individuals referred for CT-based lung cancer screening in an urban safety-net setting.

Widespread implementation of CT-based lung cancer screening is underway, but its impact on cancer morbidity and mortality can only be achieved IF people are screened at appropriate intervals and abnormal findings are appropriately assessed. The degree to which individuals, especially those from medically underserved populations with highest lung cancer risks, will adhere to the complex, multi-step process of CT-based lung cancer screening has emerged as a key question with immediate need for solution. Specific aims of the study are as follows:

* Aim 1: Compare rates of completion for clinically recommended steps in the lung cancer screening process between patients referred for CT-based lung cancer screening who are randomized to the navigation intervention versus patients who receive usual care.
* Aim 2: Compare changes in patient-reported outcomes, including satisfaction with care, psychosocial distress, and tobacco use between patients in the navigation intervention versus those who receive usual care for the CT-based lung cancer screening process.
* Aim 3 (Exploratory): Explore whether differences seen in Aims 1 and 2 are moderated theory-based patient attitudes and beliefs (perceived susceptibility, severity of lung cancer, perceived benefits/barriers to screening, self-efficacy).

This study will offer unprecedented insight into implementation of lung cancer screening for high-risk individuals in underserved settings. Findings will show whether navigation interventions increase adherence to the screening process and affect patient-reported outcomes among underserved populations. The proposed program aims to address these issues for lung cancer screening at its inception, rather than after disparities in screening uptake have already emerged.

Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System

A Randomized Controlled Trial (RCT) of Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System

Cancer Prevention Research Institute of Texas

University of Texas Southwestern Medical Center

PROFESSOR

Skin and Connective Tissue Diseases

Breast Neoplasms

Diet and physical activity intervention group. Measurements taken at baseline, 12 weeks and 1 year.

No-treatment control group. Measurements taken at baseline, 12 weeks and 1 year. People in the control condition can elect to take the intervention after 1 year.

Participants are consented and randomized into the intervention group or delayed intervention group(intervention offered one year later). Participants in intervention group attend 12 weekly sessions and 9 monthly sessions. All participants attend 3 clinics in which we collect data, measurements and blood samples. These clinics occur at baseline, 12 weeks and one year.

Lifestyle

Swann Arp-Adams, Ph.D

It is known that diet and physical affect a variety of disease-related endpoints and overall health status in general. The investigators also know that dietary and PA intervention effects are difficult for individuals to maintain. By contrast, the investigators have some evidence that group-based and family-centered, multi-component interventions are more effective in terms of creating large changes in diet-related outcomes. Using a group-randomized, controlled design, the overall goal of this project is to reduce breast cancer-related health disparities in a high-risk community, by achieving these Primary Aims,to conduct a regionally-based community-designed dietary and physical activity behavioral controlled trial among AA women,to test the effectiveness of the community-designed, family-based dietary and physical activity behavioral intervention on modifying biomarkers of inflammation and to test the effectiveness of the community-designed, family-based dietary and physical activity behavioral intervention on decreasing breast density

AAs in South Carolina bear an unequal burden of cancer incidence and mortality compared to their European American counterparts. The Research Program (RP) is committed to investigating and eliminating this burden through the careful conduct of research studies in partnership with their AA community partners. The overall aim of the RP is to support the SCCDCN-II in its mission to reduce, and ultimately eliminate, cancer health disparities using a community-based participatory research (CBPR) approach to design and conduct research projects in AA communities in South Carolina. The goals of the research program are to: support the SCCDCN by serving as a research liaison/consultant for all community-based activities; foster and support meaningful partnerships between academic researchers and community leaders and representatives; conduct a two-arm physical activity and dietary intervention trial for breast cancer prevention among African-American women in the investigators target communities of faith; conduct a pilot study to determine African-American men's and women's knowledge about prostate cancer screening and their knowledge and attitudes regarding participation in prostate cancer research, including National Cancer Institute (NCI) sponsored clinical trials; support additional research in cancer disparities through a Pilot Study post-transition year and to develop and implement an SCCDCN-II internal pilot grants program in years 4 and 5; and partner with community representatives to disseminate program findings and to work with colleagues in the AC, and Community Outreach and Training Programs to develop community capacity aimed at sustaining programs to improve health The two-arm intervention trial will be aimed at testing the effectiveness of a community-designed, family-based dietary and PA behavioral intervention on modifying biomarkers of inflammation and decreasing breast density with a randomized controlled design. The prostate cancer pilot will be aimed at assessing current knowledge and attitudes regarding prostate cancer prevention and screening, and participation in prostate cancer research; changes in knowledge and attitudes about research participation following a pilot education program; and culturally appropriate strategies for promoting cancer research among AAs in a faith-based community. All activities of the research program will be conducted in partnership with identified SCCDCN II community partners, the State Baptist YWA of the Women's BEMC, SCPHCA, CCBHSN, and Insights Consulting. It is anticipated that research activities will be conducted in all 5 years of the granting period with opportunities for research partnerships in all State Baptist YWA regions throughout the state.

Sistas Inspiring Sistas Through Activity and Support

SCCDCN-II: Research Project (Breast Cancer)

Data will be made available upon request using our data request form and with data committee approval. We will allow the data to be shared after publication of our two primary outcome manuscripts.

This will entail examining changes in the inflammatory index derived from dietary self-report and self-reported physical activity and blood samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Virtual Reality Intervention in Cancer Genetics	NCT01310829	Cancer Prevention Harm...	Questionnaires Physiological M... Virtual Reality...	18 Years -	M.D. Anderson Cancer Center
Social Contextual Influences on Physical Activity	NCT01195337	Cancer Prevention Harm...	PA Prescription... Pedometer Newsletters	25 Years - 60 Years	M.D. Anderson Cancer Center
Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System	NCT02758054	Non-Small Cell ... Compliance Beha... Prevention Harm...	Patient Navigat...	55 Years - 74 Years	University of Texas Southwestern Medical Center
Sistas Inspiring Sistas Through Activity and Support	NCT02144571	Prevention Harm...	Lifestyle	30 Years - 90 Years	University of South Carolina
Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System	NCT02758054	Non-Small Cell ... Compliance Beha... Prevention Harm...	Patient Navigat...	55 Years - 74 Years	University of Texas Southwestern Medical Center
Sistas Inspiring Sistas Through Activity and Support	NCT02144571	Prevention Harm...	Lifestyle	30 Years - 90 Years	University of South Carolina
Virtual Reality Intervention in Cancer Genetics	NCT01310829	Cancer Prevention Harm...	Questionnaires Physiological M... Virtual Reality...	18 Years -	M.D. Anderson Cancer Center

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